TREXO PLUS
Received Jan 17, 2024 · Event occurred Dec 11, 2023
Report MW5150483 · MDR key 18536150
Device
Generic name
System, Isokinetic Testing And Evaluation
Manufacturer
Trexo Robotics Holdings Inc.Model number
A0001Catalog number
A001BPR
Patient
Male
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Description of Event or Problem
DURING THE PATIENT'S THERAPY SESSION AT CLINIC, THE CHILD (WC) WALKED IN THEIR TREXO PLUS DEVICE FOR THE SECOND TIME, AS PART OF THEIR REHABILITATIVE ACTIVITIES. UPON RETURNING HOME MOM NOTICED THE FRACTURE WHICH WAS LATER CONFIRMED ON X-RAY. AFTER HEARING OF THE INCIDENT, COMPANY REPRESENTATIVE WENT TO INVESTIGATE THE DEVICE AT THE CLINIC ON (B)(6) 2023 AT 12:50PM. HE FOUND EVIDENCE OF USER ERROR ON THE DEVICE ITSELF AS A RESULT OF CLINIC SUPERVISORS FAILING TO COMPLY WITH THE TREXO PLUS USER MANUAL, AND/OR TRAINING PROVIDED BY THE TREXO CUSTOMER SUCCESS TEAM.